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Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery

NCT04734535 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-02

No results posted yet for this study

Summary

The purpose of this clinical investigation in open, elective, spine surgery is to collect data to support the removal of the neurosurgical exclusion from the currently approved indication for the use of HEMOBLAST™ Bellows. This study is primarily designed to assess safety of the device for use in spine surgery, although efficacy information will also be captured and reported.

Conditions

  • Surgical Bleeding

Interventions

DEVICE

HEMOBLAST™ Bellows

Intraoperative bleeding during epidural spine surgery will be treated with HEMOBLAST™ Bellows

DEVICE

absorbable gelatin sponge with thrombin

Intraoperative bleeding during epidural spine surgery will be treated with absorbable gelatin sponge with thrombin

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Dilon Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph Schwab, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2024-02-05
Completion
2024-02-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04734535 on ClinicalTrials.gov